Cleared Traditional

K952031 - ULTRASOUND TRANSDUCER, MODEL US917

K952031 is an FDA 510(k) clearance for ULTRASOUND TRANSDUCER, manufactured by Advanced Medical Systems, Inc.. The device is a Class 2 Obstetrics & Gynecology device with product code HGL cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K952031 · Advanced Medical Systems, Inc. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
78d
Days
Class 2
Risk

K952031 is an FDA 510(k) clearance for the ULTRASOUND TRANSDUCER, MODEL US917. Classified as Transducer, Ultrasonic, Obstetric (product code HGL), Class II - Special Controls.

Submitted by Advanced Medical Systems, Inc. (Hamden, US). The FDA issued a Cleared decision on July 18, 1995 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2960 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advanced Medical Systems, Inc. devices

FDA 510(k) Submission Details - K952031

510(k) Number K952031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1995
Decision Date July 18, 1995
Days to Decision 78 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 160d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HGL Device Classification - Class 2, Special Controls

Product Code HGL Transducer, Ultrasonic, Obstetric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2960
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HGL Transducer, Ultrasonic, Obstetric

All 23
Devices cleared under the same product code (HGL) and FDA review panel - the closest regulatory comparables to K952031.
OP3/VP4
K924516 · Huntleigh Technology, Inc. · Jun 1993
ULTRASONIC PULSED DOPPLER IMAGING SYSTEM
K903348 · Advanced Technology Laboratories, Inc. · Oct 1990
EUP-V12 5.0 MHZ CONVEX ARRAY TRANSVAGINAL PROBE
K900966 · Hitachi Medical Corp. of America · Sep 1990
ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER
K903316 · Ge Medical Systems Information Technologies · Aug 1990
ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM
K895449 · Ge Medical Systems Information Technologies · Mar 1990
5.0 MHZ CONVEX ARRAY INTRAVAGINAL TRANSDUCER
K895647 · Advanced Technology Laboratories, Inc. · Dec 1989